{"classes":[{"categories":[{"measurements":[{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"NA: Not estimable due to the insufficient number of participants with events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"484"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"TTR was defined as the time from randomization to the first documented and confirmed response (CR or PR) as defined by RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise.\n\nCR: Disappearance of all lesions with lymph nodes measuring \\< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.","id":"OG000","title":"Ribociclib + Fulvestrant"},{"description":"Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.","id":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"MEDIAN","populationDescription":"FAS including all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization to first response, assessed up to approximately 26 months","title":"Time to Response (TTR) Per Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Months"}